BEUDAMED
    FDA Enforcement Class II Ongoing

    Hanger-Bar 2P 45cm

    Recall: Z-0852-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0852-2022
    Event ID
    89509
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Human Care USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2022
    Initiation Date
    November 1, 2021
    Classification Date
    March 31, 2022
    Address
    4210 S Industrial Dr Ste 160, N/A, Austin, TX, 78744-1077, United States

    Description

    Hanger-Bar 2P 45cm

    Reason

    The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

    Code Info

    Part Number 72755 UPC Code: 881608800403 EAN Code: 7331599999714 Lot Number: 33164504

    Distribution

    U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV.

    Quantity

    15 devices